The aim of the study is to assess the effect of Alfuzosin compared with placebo, for 7 days, on the outcome of patients with uretheric stones submitted to Extracorporeal Shock Wave Lithotripsy (ESWL), namely in the percentage of patients without imagiologic evidence of any stone after 72h to 96 hours. This study will also specifically focus on the evaluation of time of stone clearance and of pain reduction (Numeric Rating Scale).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
220
Sanofi-Aventis
Lisbon, Portugal
Safety: General clinical safety by collection of spontaneously reported adverse events
Time frame: at each visit
Efficacy: Percentage of patients without imagiologic evidence of any stone
Time frame: 72h to 96 hours after ESWL
Percentage of patients without imagiologic evidence of any stone
Time frame: 24 hours after ESWL
Percentage of patients with clinical evidence of stones clearance
Time frame: 72h to 96 hours after ESWL
Time for stone clearance (clinical evaluation)
Numeric Rating Scale scores
Time frame: at 24h, (48h, if applicable), 72-96h and 7 days
Need for rescue analgesic medication.
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